4 results
This study, a three-phased cross-over study, aims to define a proper formulation for oral and oromucosal melatonin by investigating the Tmax and relative bioavailability derived from melatonin levels in salivary samples of healthy volunteers after…
Primary:To evaluate the effects of 15 mg E4/3 mg DRSP, of 30 mcg EE/150 mcg LNG, and of 20 mcg EE/3 mg DRSP on hemostasis, endocrine function and lipid and carbohydrate metabolism parameters during 6 treatment cycles.Secondary:To assess the safety…
Primary- To evaluate the effects of the 15 mg E4/3 mg DRSP combination and the 20 mcg EE/3 mg DRSP used as reference combination on ovarian function inhibition at Treatment Cycle 1 and Treatment Cycle 3.Secondary- To evaluate levels of luteinizing…
Primary ObjectivesPhase 2The primary objectives of Phase 2 are:• To evaluate short- and long-term safety and tolerability of SNDX 5613.• To assess the CR+CRh rate. Secondary ObjectivesPhase 2Secondary objectives of Phase 2 are:• • To assess…